FDA.reportPublic FDA data

Application 075352

Type
ANDA
Sponsor
DAVA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SELEGILINE HYDROCHLORIDESELEGILINE HYDROCHLORIDECAPSULE;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-737Selegiline HydrochlorideSelegiline HydrochlorideMarlex Pharmaceuticals, Inc.ANDACurrent
60429-019SELEGILINE HYDROCHLORIDESELEGILINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-019SELEGILINE HYDROCHLORIDESELEGILINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
67253-700SELEGILINE HYDROCHLORIDESELEGILINE HYDROCHLORIDEPar PharmaceuticalANDACurrent
67253-700SELEGILINE HYDROCHLORIDESELEGILINE HYDROCHLORIDEPar PharmaceuticalANDACurrent
68151-2649SELEGILINE HYDROCHLORIDESELEGILINE HYDROCHLORIDECarilion Materials ManagementANDACurrent
70954-504Selegiline HydrochlorideSelegiline HydrochlorideNovitium Pharma LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8629ORIG1998-11-30